Doctors and Dentists Exemption Certificate (now incorporated into the CTA)

DLT

Drug Limiting Toxicity

DM

Data Management

DMC

Data Monitoring Committee

DMEC

Data Monitoring and Ethics Committee

DoH

Department of Health (UK)

Double Blind

A trial where neither the participants nor the researchers know who belongs to the control group and the experimental group. A double blind trial is a way to lessen the potential for bias on the results.

DQF

Data Query Form

DSMB

Data Safety Monitoring Board

EC

European Commission

eCRF

Electronic Case Report Form

EDC

Electronic Data Capture

EMEA

European Medicines Agency

EMWA

European Medical Writers Association

EU

European Union

EU CTD

European Union Clinical Trial Directive

EudraCT

European Clinical Trial Database

EudraVIGILANCE

European Database for Pharmacovigilance

FDA

Food & Drug Administration (USA)

GAfREC

Governance Arrangements for Research Ethics Committees

GCP

Good Clinical Practice

GLP

Good Laboratory Practice

GMP

Good Manufacturing Practice

IB

Investigator’s Brochure

ICF

Informed Consent Form

ICH GCP

International Conference on Harmonisation Good Clinical Practice

ICR

Institute of Clinical Research

IMP

Investigational Medicinal Product

IMPD

Investigational Medicinal Product Dossier

Investigator

Clinician or nurse involved in a clinical trial

IRB*

Institutional Review Board / Independent Review Board

ISF

Investigator Site File

ISRCTN

International Standard Randomised Controlled Trial Number

LOA

Letter of Access

MA

Marketing Authorisation

MAH

Marketing Authorisation Holder

MedDRA

Medical Dictionary for Regulatory Activities (global standard medical terminology used in the medical product development process)

MHRA

Medicines and Healthcare products Regulatory Agency

MRC

Medical Research Council

MREC

Multi-centre Research Ethics Committee

MS

Member State

MTD

Maximum Tolerated Dose

NDA*

Non-Disclosure Agreement

NDA*

New Drug Application (FDA)

NHS R&D

National Health Service Research & Development

NHS REC

National Health Service Research Ethics Committee

NICE

National Institute for Health and Clinical Excellence

NRES

National Research Ethics Service (formerly COREC – Central Office for Research Ethics Committees)

OTC

Over-the-Counter (refers to non-prescription drugs)

Participant

Person participating in a clinical trial

PD

Pharmacodynamics

Phase I

Phase I or Healthy Volunteer Studies are non-placebo controlled, small studies, and the first test of a drug in humans.